Don't Be Nervous About Hormone Therapy for Menopause, Says NAMS

Pam Harrison

June 30, 2017

Editor's note: An earlier version of this story erroneously indicated that ospemifene was available over the counter.

A new position paper on the use of hormone replacement therapy (HRT) for menopausal and postmenopausal women has now been released by the North American Menopause Society (NAMS) and guarantees to make healthcare providers and the women they treat more comfortable using HRT when women want it to improve their quality of life.

"There continues to be confusion and fear for both women and their healthcare providers about the use of hormone therapy for menopausal women," JoAnn Pinkerton, MD, executive director of NAMS and professor of obstetrics and gynecology, University of Virginia Health System in Charlottesville, told Medscape Medial News in an email.

"NAMS's goal with this new position statement on hormone therapy is to give women and providers confidence about using hormone therapy for symptomatic menopausal women when it is indicated," she added.

The new position statement was published online June 21 in Menopause.

NAMS hinted at what would be in its updated position statement on HRT use during its annual meeting in 2016, as reported by Medscape Medical News, with the focus being on the fact that HRT has more benefits than it does risks for healthy women under the age of 60 who are within 10 years of menopause.

"The concept of 'lowest dose for the shortest period of time' may be inadequate or even harmful for some women," the statement authors affirm.

"A more fitting concept is 'appropriate dose, duration, regimen, and route of administration,'  " they add.

Who Should Get HRT?

The Food and Drug Administration (FDA) has approved hormone therapy for four indications: bothersome vasomotor symptoms (VMS); prevention of bone loss; estrogen deficiency caused by hypogonadism, castration, or premature ovarian insufficiency (POI); and genitourinary symptoms.  

For vasomotor symptoms or hot flashes, conjugated equine estrogen (CEE) alone may be offered to women provided they have had a hysterectomy. For women with an intact uterus, CEE must be combined either with a progestogen or with bazedoxifene, a selective estrogen-receptor modulator (SERM), to protect users against endometrial cancer.

Alternatively, studies indicate that micronized progesterone at a dose of 300 mg a night significantly reduces hot flashes and night sweats and improves sleep, the NAMS statement authors indicate.

For vaginal symptoms (vulvovaginal atrophy [VVA]), the writing group recommends low-dose, intravaginal estrogen preparations that have minimal systemic absorption. (These same preparations may be considered in women with a history of breast cancer in consultation with their oncologist).

Women with VVA who do not wish to or who cannot take estrogen preparations may be counseled to try ospemifene or intravaginal DHEA.

And "systemic HRT does not improve urinary incontinence and may increase the incidence of stress urinary incontinence," the NAMS authors caution.

On the other hand, low-dose vaginal preparations of estrogen may alleviate urinary systems as well as sexual-function difficulties in women with symptomatic VVA.

HRT cannot be expected to improve sexual function or arousa,l but if a woman expresses concerns about sexual function or libido, transdermal estrogen may be the route to go, as it has less of an effect on testosterone levels than systemic estrogen. Testosterone is critical to the preservation of libido.

Women who enter early menopause naturally, surgically, or because of POI are all at high risk for estrogen-deficiency–related consequences and should be considered early on for treatment with estrogen, plus some form of endometrial protection for women with an intact uterus.

"For women with hypoestrogenism, POI, or early menopause —whether natural, surgical, or induced — HRT is recommended until at least the median age of menopause at 52 years," Dr Pinkerton noted.

What to Do About Hormone Therapy for BRCA 1/2 Carriers

As for women who carry the BRCA 1/2 mutation, both of which place them at very high risk for breast and ovarian cancer, Dr Pinkerton pointed out that observational studies suggest that hormone therapy does not alter the risk for breast cancer further in women with a family history of it, although family history must be assessed when counseling women about HRT.

"For BRCA-positive women without breast cancer who have undergone risk-reducing bilateral salpingoophorectomy, observational data suggest that systemic HRT to the median age of menopause may decrease health risks associated with premature loss of estrogen without increasing breast-cancer risk," she said.

"But more data are needed in this group," Dr Pinkerton acknowledged.

What About Older Women and Extended Use of HRT?

Finally, the NAMS authors caution that when HRT is initiated in women who are 10 or more years out from the menopause or when they are 60 years of age or older, the benefit/risk ratio of HRT is less favorable than it is for younger women.

As such, initiation of treatment in this older age group must be approached with clear caution, although a discussion about the benefits and risks of HRT in older women may be considered for women who choose to initiate or restart HRT.

As the NAMS authors note, once women discontinue HRT, there is about a 50% chance that vasomotor symptoms will return, regardless of their age or how long they've been using it.

Thus, extended use of HRT may be expected to continue to relieve persistent VMS, they note.

"With discontinuation of HRT, virtually all women will lose [bone-mineral density], with increased risk of bone fractures and excess mortality from hip fracture," they also point out.

Moreover, there is no evidence to support routine discontinuation of HRT after the age of 65, as Dr Pinkerton stressed.

"Decisions about longer duration of therapy should be individualized and considered for indications such as persistent vasomotor symptoms or bone loss, with shared decision-making, documentation, and periodic reevaluation," she emphasized.

"And the risks of longer use of HRT may be minimized with the use of lower doses of both estrogen and progestogens, the use of transdermal therapies to avoid hepatic first-pass effect, or the combination of conjugated estrogen paired with the SERM bazedoxifene, which provides endometrial protection without the need for a progestogen," she added.

That said, the NAMS authors point out that estrogen alone has a more favorable safety profile than estrogen plus progestogen and as such may be the more appropriate choice for longer duration of therapy.

Dr Pinkerton reports serving as a consultant for Pfizer, with the fee paid to her institution, as well as an investigator for TherapeuticsMD, with fee similarly paid to her institution. Disclosures for the advisory board and coauthors are listed in the paper.

Menopause. Published online June 21, 2017. Abstract

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